AHC Supports Improving and Simplifying the FDA Approval Process for Animal Drug Products

The Food and Drug Administration (FDA) requested comments on strategies to address the amount of animal drug products currently marketed in the U.S. without approval or other legal marketing status.  The FDA is concerned that the safety and effectiveness of these actively-marketed products has not been demonstrated.  The purpose of FDA’s initiative was to request comments on approaches for increasing the number of legally-marketed animal drug products.

Background

Historically, issues surrounding efficacy, safety, and regulatory oversight have sometimes caused uncertainty for equine veterinarians.  Furthermore, many horse owners are not aware of the difference between approved and unapproved drugs or the possible lack of efficacy when their horses are treated with unapproved or illegally compounded drugs.

New animal drugs cannot be legally marketed unless they have been reviewed and approved, conditionally approved, or index-listed by FDA.  The purpose of an FDA approval is to ensure the drug’s strength, quality and purity are consistent from batch to batch and the drug’s labeling is appropriate and truthful.

Currently, there is a fair amount of uncertainty for horse owners and equine practitioners in determining the safest and most effective treatment for their horse and whether FDA has approved the medications for that treatment.

Rule Proposal

The purpose of FDA’s request was not to revise the current approval process, but to explore additional ways to increase the number of approved or otherwise legally-marketed animal drugs under FDA’s existing regulatory framework.

The FDA also requested input on the use of limited enforcement discretion as an element of the overall approval strategy.  Enforcement discretion allows FDA, under limited circumstances, to maintain access to essential unapproved animal drugs while drug companies work to get these drugs on the market legally.

AHC Comments

The AHC noted the current framework for drug approval results in an economic disincentive for pharmaceutical companies to develop new animal drugs through the full FDA approval process.  The time and cost required to demonstrate that the manufacturing process can reliably produce drug products of expected identity, strength, quality, and purity, combined with the relatively narrow profit margins for most animal drugs, sometimes results in a lack of available legally-marketed animal drug products in the U.S.

Because not all drugs needed to treat equine diseases are approved by FDA for horses, equine practitioners often use a number of human medications off extra-label.  This is a logical and safe way to utilize drugs that have been proven by clinical use or experimentation to be efficacious and safe for horses.  In fact, some of these medications were once produced primarily for horses but were subsequently removed from the market due to a lack of profitability.  Other medications, such as intravenous lidocaine and diazepam, have not undergone the full FDA approval process for use in horses, but there is considerable literature and clinical documentation on supporting their efficacy and safety. 

Equine practitioners are sometimes forced into a precarious position in which they must be versed in the variations between licensed and actively regulated products as well as those that are not licensed and not regulated.  Additionally, equine veterinarians rely on the well established practice of drug compounding; however, drug compounding exposes the equine practitioner to potential liability if the compounding pharmacy does not follow the Good Manufacturing Practices (GMPs) guidelines enforced by FDA.

There are major concerns about the use of products marketed as devices but used systematically as treatments, such as a device marketed for joint lavage but used intravenously by practitioners.  Though anecdotal evidence suggests these devices are not harmful, their effect on horse health and efficacy has rarely been documented by rigorous scientific studies.

Use of enforcement discretion is still needed for specific drugs necessary for treating specific conditions but not yet approved for horses.  However, excessive use of discretion fosters the use of illegally compounded drugs and untested devices creating less incentive for companies to invest in the testing for new drug development and placing horse health at risk.  This lack of enforcement fosters the misuse of drugs and leaves the horse industry susceptible to treatment recommendations based on cost savings rather than efficacy.

The AHC agrees with the proposal to use drug monographs or publically available information to provide information about currently unapproved animal drugs.  Furthermore, creation of a panel of scientist and clinicians to work with the FDA is recommended as a logical way to evaluate drugs for conditional approval, based on currently available experimental documentation or clinical use, without going through the entire FDA approval process.

The AHC reiterated its support of FDA’s important effort to improving the simplicity in which equine practitioners can obtain approved medications, and the AHC believes modifications to the FDA approval process will not only improve the general health care for horses but will also mitigate some of the current economic burdens on the horse industry.

Status

FDA asked for public comment on the specifics of the proposed rule on February 18, 2011, the AHC submitted comments supporting FDA’s willingness to consider alternative avenues to improve the simplicity, reduce the economic burdens, and minimize the time in which animal drug products are approved and available for use in the U.S.

FDA is currently reviewing AHC’s comments, and the Agency extended the comment period for those interested in offering additional recommendations on improving and simplifying FDA’s approval process for animal drugs.

AHC Position

The AHC supports increasing the number of legally-marketed animal drug products for use in horses and improving the simplicity by which equine veterinarians can obtain approved medications with assurances to the drug’s efficacy and safety.